WO2008080990A1 - Infusion device that can be worn outside the body - Google Patents

Abstract

The invention relates to a portable medical device for the dosed administering of a liquid medicament, which comprises: a) a first housing with a reservoir unit (1) with an outlet into a fluid line situated downstream of the reservoir unit (1) for passing the medicament through, b) a second housing with a delivery unit (2) for the dosed dispensing of the medicament from the reservoir unit (1) and suitable means for controlling the delivery unit (2), c) an adapter with coupling means (5; 20, 23) for receiving the first housing with the reservoir unit (1) and a second housing with the delivery unit (2) d) and fastening means (6; 8; 21) for the adapter to be carried along on the patient's body, e) wherein the delivery unit (2) and the reservoir unit (1) can be joined together to form a complete mechanical and fluidic unit, preferably at least largely without any tools, f) and can be coupled to at least two differently designed adapters (3a, 3b; 3c, 3d) and can be uncoupled from them and, as a result, can be joined together with the respective adapter to form a complete mechanical and fluidic unit, preferably at least largely without any tools, g) and wherein at least one of the adapters (3a; 3c) is intended for fastening directly to the surface of the skin and at least one other of the adapters (3b; 3d) can be worn on a garment by means of a carrying system.

Description

 Lawyer's file: 56 476 XI Disetronic Licensing AG

Extracorporeal portable infusion device

The invention relates to a device for the automated dispensing of a liquid medicament according to the preamble of patent claim 1.

Devices for the automated and continuous dispensing of liquid medicaments are preferably used in patients who have a continuous and varying throughout the day demand for a drug which can be administered exclusively subcutaneously. Specific applications are z. For example, certain pain therapies and the treatment of diabetes mellitus employing portable, computer-controlled delivery devices on the body. There is a general need for low weight and minimum device volume of the delivery device to allow for convenient and discrete wearing.

In the prior art conventional, extracorporeal infusion devices for therapeutic use are common, which are carried by means of a carrying system on the body or in the clothes. During the sleep of the patient, they are usually placed on a fixed storage area next to the bed and remain in communication with the body via a catheter delivery, while maintaining fluid administration.

Recently, miniaturized infusion devices which are attached directly to the surface of the skin are available. The application of the administering device to the skin surface and the introduction of the administration cannula into the body tissue is performed by the patient by hand. After such an infusion device has been attached to the skin surface, it usually sticks to the body for 4 to 5 days and is then disposed of in whole or in part. Both the attached to the skin surface and the conventional infusion devices have type-specific and situational advantages and disadvantages. Thus, it is desirable, for example, in everyday use of the patient that the infusion device, at least partially, temporarily removable, for example, pursue unhindered sporting activity or to suspend precision parts or electronic components of the administering device in a showering or bathing not unwanted water contact.

With a conventional delivery device, a temporary removal is possible by a temporary deconnection of the catheter tube, with a suitable sealing of the coupling points. Similarly, the replacement or replacement of disposable aids, e.g. Insulin ampoules, batteries, catheters in the conventional administration devices easily feasible, since the devices are designed for a long life.

In contrast, because of the consistently one-time use and low manufacturing cost concept, the delivery devices carried on the skin surface do not permit either temporary deconnection or replacement of parts of the delivery device. For physical activities such. As sports, swimming or body cleaning a patient-friendly, temporary Dekonnektierung from the body is not possible. Even with severe miniaturization of delivery devices carried on the surface of the skin, the patient is restricted in freedom of movement, since a certain component volume is still arranged on the body and a static imbalance restricts the wearer's comfort. Furthermore, there is a risk that the device by insufficient adhesion to the body, for example, when attached by means of a plaster, dissolves from the body or is torn by jerky movements of the body. Furthermore, the injection sites and the support points are limited for this concept. As advantages of delivery devices carried on the skin surface, discreet, discrete wearing and short fluid connections should be noted. EP 1527792 A1 describes a delivery device which can be fastened on the skin surface, but which is not temporarily de-connectable and largely corresponds to the preamble of claim 1.

It is an object of the invention to provide a portable medical device for the metered administration of a liquid medicament, which can optionally be worn directly on the body surface and also carried in a conventional manner by the patient, depending on what is desired in the particular situation.

The object is solved by the subject matter of claim 1. Advantageous embodiments will be apparent from the dependent claims.

The invention is based on an extracorporeally portable infusion device which has a reservoir unit with a reservoir for a liquid medicament and a delivery unit for metered delivery of the medicament. The delivery unit comprises suitable means for delivery and metered distribution of the drug.

The invention is not limited to the administration of insulin, but generally extends to the administration of products which are infusible. Comparable devices can be used not only in self-administration, but also in the inpatient area, for example under constant medical supervision in hospitals, for example in rehabilitation or other aftercare, where they are worn by the patient.

In a preferred embodiment of the administration device, the device is designed such that the delivery unit and the reservoir unit of the portable administration device can be mechanically and functionally assembled or separated by means of coupling means. In this case, the delivery unit, reservoir unit and an adapter, which may comprise a preferably flexible or optionally rigid adapter plate for a support on the clothing or directly on the body, combined to form an integrated unit. In preferred embodiments, one or more coupling means on the conveyor unit and one or more coupling means on the reservoir unit, preferably each non-removable without tools, z. B. by integrally molded with the respective housing or materially connected or otherwise firmly joined, for example, are screwed. This has the advantage that the coupling means are captive molded or connected to the respectively associated one of the two units and thus are available at all times.

In a preferred embodiment, said units of administration device (pump), reservoir and delivery unit are coupled to a fluidic-mechanical connector of the adapter, which fixes both the units relative to the adapter, preferably the adapter plate, as well as a fluidic connection between the reservoir unit and ensuring a cannula infusing the body for a preferably subcutaneous administration. The connector is advantageously arranged in the middle of the adapter plate. The mechanical coupling to the connector can be done non-positively by clamping to the connector or positively by formation of a counter-contour through the connected housing parts of the reservoir and conveyor unit.

In a further preferred embodiment of the device, the coupling means are configured so that the assembly of reservoir unit and conveyor unit by moving them relative to each other, for example along rigid guides, in particular by pushing along linear guides, such as linear dovetail guides, or by a Bajonettverschluss formed by both units. Such a type of coupling allows accurate positioning of the two units to each other and also facilitates in particular a hand-joining of reservoir unit and conveyor unit in inaccessible or difficult to see places, eg. B. at the side of the belt attached adapter plate.

Preferably, the coupling means are designed such that the assembly of the delivery unit and the reservoir unit can be effected by latching of locking elements. Such coupling means usually come without additional securing means. In yet another preferred embodiment, the coupling means are designed such that the assembly of reservoir unit and conveyor unit is non-positively, preferably by clamping, or temporary bonding, magnetic force or via Velcro pairing. Also, the coupling means may be configured such that the assembly of reservoir unit and conveyor unit takes place under stretching of one or more rubber-elastic molded elements formed by the unit, which (s) in the assembled state by enclosing or engaging in one or more mating contours with a resiliently biased positive connection associated, preferably rigid form elements of the complementary unit. This makes it possible to realize a backlash-free coupling in a cost-effective and simple manner.

In a particularly preferred embodiment, the units are attached to the surface of the skin by means of an adapter with preferably an adapter plate, which remains on the skin surface during the temporary deconnection and forms a so-called detention part, via a detachable adhesive bond or a skin plaster. This embodiment combines the advantages of the discrete carrying possibility of the body-mounted extracorporeal infusion devices with the patient-friendly possibility of a temporary deconnection.

In a particularly preferred alternative embodiment, the pump parts are coupled via an adapter with preferably an adapter plate for entrainment on a support system of the patient. Such an adapter plate is configured such that connecting means are present to a carrying system, in particular a suspension loop, a body-comprehensive belt loop, a belt clip or a fastening possibility to a garment. This makes it possible in a simple manner to adapt the infusion device by replacing the carrying system to different everyday situations or uses. The device with the pump parts and the adapter plate can be worn as a whole on a belt. For this purpose, a lateral cannula connection to the adapter plate is necessary. On the resulting flat underside of the adapter plate, one or more fastening clips or a belt loop can be attached. In a particularly preferred embodiment, when using an adapter plate for entrainment to a carrying system, a dekonnektierbarer catheter head, with a cannula for introduction into the body tissue, connected via a short catheter lead to the adapter plate Dekonnektierbare catheter heads are known in the art and are standard in the Pump therapy used. In such an embodiment, a septum on the fluidic-mechanical connector of the adapter plate is unnecessary.

In a still further particularly preferred embodiment of the device, the coupling means comprise securing means by means of which the reservoir unit and the conveying unit can be secured in the intended assembled state, preferably against unintentional separation. It is preferred if the securing means for canceling the backup require manipulation, which is different from the manipulation required for separation, thus requiring, for example, a pressing of a release button, when a rotational movement is required for the separation. This allows a maximum of security against accidental separation and loss can be achieved.

In a further particularly preferred embodiment, electronic means are preferably provided on the device, which bring about a secure resting state of the infusion device before separation and, after the merging, enable a continuation of the administration according to the program.

In likewise particularly preferred embodiments, the delivery unit optionally consists of a single-use or multiple-use delivery unit, the reservoir unit optionally of single-use or single-use reservoir unit, and the embodiments of the adapter plates optionally for single use or multiple use.

Further preferred embodiments of the invention will become apparent from the dependent claims and from the following description with reference to FIGS. Showing: 1 shows a reservoir unit, a conveyor unit and an adapter plate for direct

Attachment to the skin surface; Figure 2 shows an adapter plate for carrying on a carrying system in the form of a body-encompassing belt, wherein a short length of catheter tube on the

Adapter plate is attached, showing the distance between the carrying position and

Cannula entry position overcomes; Figure 3 shows an adapter plate for direct attachment to the skin surface, wherein the

Fluid supply in the adapter plate extends; Figure 4 shows an adapter plate for carrying on a carrying system, wherein the

Fluid supply in the adapter plate runs.

FIG. 1 shows an infusion device according to the invention with a couplable delivery unit (2) and a reservoir unit (1) which is fastened to the skin surface (7) by means of an adapter plate (3a) according to the invention. Due to a complete attachment of the infusion device to the body surface, under certain circumstances, high weight and acceleration forces can arise, accordingly, a strong adhesive plaster (6) must be selected, which adheres well but is easy to remove at the same time.

The disadvantages of a permanently attached to the body device can be solved so that the reservoir unit (1) and the conveyor unit (2) containing the drive unit (12) and the electronics (13) are attached via an adapter to the body. The adapter has an adapter plate (3a) resting on the skin and a fluidic-mechanical connector (5) protruding therefrom. The units (1) and (2) via the connector (5) by means of simple handles of the adapter plate (3a) solvable while it can remain on the body, and thus temporarily removable from the body, for example, unhindered to pursue a sporting activity or order Do not subject precision parts or electronic components of the delivery device to unwanted water contact during a showering or bathing session. The connection of the delivery unit (2), reservoir unit (1) and adapter (3a, 5) by coupling means (4) which act by snapping, screws or by a quick release (eg levers and straps, buckle). The adapter (3a, 5), with an integrated cannula (14) for insertion into the body tissue (7), serves as a connection and fastening system of the insulin pump and connects the conveyor unit (2) with the reservoir unit (1). A septum (15) prevents the escape of body fluid from the body during a temporary disconnection. An injection needle (16) which can be introduced on the fluidic-mechanical connector (5) permits a penetration of the body tissue (7) during the application of the cannula (14). The reservoir unit can be used as a supporting housing part with the advantage that the whole unit unit can be constructed very compact and flat. An additional ampoule compartment, as used in conventional insulin pumps, is omitted in this arrangement. The handling is also simplified, since no additional adapter is necessary in order to connect the reservoir unit (1) and the delivery unit (2) mechanically and the former also fluidly to the cannula (14). The reservoir unit (1) is designed so that no additional promotion due to external forces can occur due to existing reinforcements (eg ribs).

FIG. 2 shows an adapter plate (3b) for an administering device, which is carried along the patient's body via a carrying system. As an alternative to a body-mounted carrying by means of adapter plate (3a), the reservoir unit (1) and the conveyor unit (2) with the adapter plate (3b) are combined, which via a short (<50 cm) catheter (10) the fluidic connection to the catheter head (11) and by means of belt support system (8, 9) can be carried by the patient on the body. Due to the predominant absorption of the forces on the carrying system, it is possible to use a smaller plaster (16) for cannula attachment, whereby the risk of skin irritation is reduced and fastening problems can be reduced. In order to enable a temporary deposition of the infusion device, the catheter head is designed to be de-connectable. A decoupling of the reservoir unit (1) and the conveyor unit (2) is not mandatory in this case. In such a case, the septum in the connector is unnecessary.

Figure 3 shows another embodiment of an adapter plate (3c) for direct attachment to the skin surface, in which a catheter supply line (19) downstream of the reservoir unit (1) is integrated into the adapter plate and can be worn directly on the skin surface. The cannula (18) is located in the middle of the adapter plate (3 c) and surrounded by symmetrically arranged skin patch or adhesive. This arrangement causes the forces acting on the injection site are the same on all sides and thus the wearing comfort is increased. The fluidic connection between the reservoir unit (1) and the adapter unit (3c) takes place with a septum / needle connection (20). The mechanical Konnektierung via each end-mounted mechanical coupling means (23).

Figure 4 shows an embodiment of an adapter plate (3d), which is provided for carrying on a carrying system. The fluidic connection between the reservoir unit and the adapter unit (3d) takes place via a septum / needle connection (20), the subsequent catheter supply line (19) is integrated into the adapter plate. The mechanical Konnektierung via each end-mounted mechanical coupling means (23). The downstream catheter supply line (22) is attached to adapter plate, fixed or detachable. In a representation, not shown, the catheter lead can also lead away laterally of the adapter plate, for example, to allow attachment to a belt. At the front ends of the adapter plate (3d) mounting options (20) are mounted for a carrying system.

LIST OF REFERENCE NUMBERS

1 reservoir unit

2 conveyor unit

3 a Adapter plate for direct attachment to the skin surface 3b Adapter plate for a carrying system

3 c Adapter plate for direct attachment to the skin surface 3d Adapter plate for a carrying system

4 coupling means (reservoir unit / conveyor unit)

5 Fluidic-mechanical connector

6 releasable adhesive or skin patches

7 skin tissue

8 connecting means to a carrying system

9 body-comprehensive belt loop

10 catheter lead Disconnectable catheter head with insertion cannula Drive unit for the delivery unit Control unit Cannula Septum Needle for inserting the cannula into the body tissue Skin patch in adapter plate Integrated cannula Needle lead, integrated in adapter plate Septum / needle connection Attachment for connection with a carrying system Catheter lead to a catheter head with cannula Mechanical coupling means for receiving conveyor / reservoir unit

Claims

claims A portable medical device for the metered administration of a liquid medicament, comprising: a) a first housing having a reservoir unit (1) with an outlet into a downstream of the reservoir unit (1) located fluid path for the passage of the drug, b) a second housing with a delivery unit (2) for the metered delivery of the medicament from the reservoir unit (1) and suitable means for controlling the delivery unit (2), c) an adapter with coupling means (5; 20, 23) for receiving the first housing with the reservoir unit (1 ) and the second housing with the delivery unit (2) d) and attachment means (6; 8; 21) for extracorporeal entrainment of the adapter on the patient, e) wherein the delivery unit (2) and the reservoir unit (1) to a mechanical and fluidic total unit can be joined, preferably at least largely without tools, f) and at least two differently configured adapters (3a, 3b, 3c, 3d) coupled bar and can be decoupled from these and thereby be combined with the respective adapter to a mechanical and fluidic total unit, preferably at least largely without tools, g) and wherein at least one of the adapter (3 a; 3 c) for direct attachment to the skin surface and at least one other of the adapters (3b, 3d) can be carried on a garment by means of a carrying system. 2. Portable medical device according to claim 1, characterized in that coupling means (4), which enable a mechanical and functional coupling between the conveyor unit (2) and the reservoir unit (1), at least substantially on the conveyor unit (2) and the reservoir unit ( 1) are formed. 3. Portable medical device according to one of the preceding claims, characterized in that the conveying unit (2), the reservoir unit (1) and the respective adapter (3a, 3b, 3c, 3d) via an at least largely without tools producible frictional or positive connection with each other are connectable. 4. Portable medical device according to one of the preceding claims, characterized in that the adapters (3a, 3b) each have an adapter plate for resting on the skin or clothing and a molded or joined to the adapter plate connector (5) for a mechanical and fluidic Connection between the reservoir unit (1) and the conveyor unit (2) on the one hand and the respective adapter on the other hand. 5. Portable medical device according to one of the preceding claims, characterized in that the delivery unit (2) and the reservoir unit (1) to a fluidic-mechanical connector (5) of the respective adapter can be fastened and fluidly connected to an outlet of the adapter. 6. Portable medical device according to one of the preceding claims, characterized in that the delivery unit (2) and the reservoir unit (1) on a fluidic-mechanical connector (5) of the respective adapter are positively or non-positively joined together. 7. Portable medical device according to one of claims 1 to 5, characterized in that either the delivery unit (2) or the reservoir unit (1) with a fluidic-mechanical connector (5) of the adapter is non-positively or positively joined together. 8. A portable medical device according to one of the preceding claims, characterized in that the dwell-forming adapter (3a; 3c), preferably an adapter plate (3a; 3c) of the adapter, via a releasable adhesive bond or a skin patch (6) on the skin surface (7) is fastened. 9. Portable medical device according to one of claims 1 to 8, characterized in that the adapter, preferably an adapter plate (3b; 3d) of the adapter, via connecting means (8) to a carrying system, in particular a neck loop, a body-comprehensive belt loop (9). , a belt clip or attachment to a garment has. 10. Portable medical device according to the preceding claim, characterized in that the connecting means (8) are equipped with securing means against unintentional separation from the carrying system. 11. Portable medical device according to one of the two preceding claims, characterized in that the intended for wearing on clothing adapter, preferably an adapter plate (3b) of the adapter, via a catheter line (10) with a dekonnektierbaren catheter head (11) for infusion of the drug connected is. 12. Portable medical device according to one of the preceding claims, characterized in that means are provided which can bring about a separation before a secure state of rest of the infusion device, preferably automatically triggered by the separation, and after merging a continuation of a routine administration allow, preferably automatically triggered by the merge. 13. Portable medical device according to one of the preceding claims, characterized in that the conveyor unit (2) optionally consists of a conveyor unit for single use or for multiple use. 14. Portable medical device according to one of the preceding claims, characterized in that the reservoir unit (1) is provided for single use. 5. Portable medical device according to one of the preceding claims, characterized in that at least the portable on the skin adapter (3a, 3b, 3c, 3d) is provided for single use only.